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Life Threatening? No
Write-up: This spontaneous report as received from a physical therapist, the mother of the patient, refers to a 14 year old female patient. The patient''s medical history was unknown. On an unknown date in August 2013 the patient was vaccinated with GARDASIL dose 1 (dosage unknown), intramuscularly. With no adverse effects. On an unknown date in December 2013 the patient was vaccinated with GARDASIL dose 2 (dosage unknown), intramuscularly (IM) in the deltoid, about two fingers below the insertion of the deltoid, (where the IM injection should be). The patient''s concomitant medications were not reported. On an unknown date in December 2012 the injection site immediately became red, swollen and very painful. The reporter reported that the swelling was determined at that time to be a hematoma. The patient couldn''t raise her arm above shoulder level without severe pain (disability), and that she had trouble in pronating and supinating her arm (disability). She stated that the patient reports feeling depression, cries a lot, concerning the loss of function and that the patient couldn''t participate in sports and activities. It was reported that the patient had seen many sports medicine doctors. An ultrasound was performed at an unspecified date and the mass surrounding the injection site was determined to be deltoid based, and was possibly necrotic. It was reported that the injury to rotator cuff was ruled out by the physician. She reported that the non-pharmacological pain relief had not been effective such as E-STEM and heat and ice. The outcome of the events was reported as not recovered/not resolved. The reporter stated that the physician stated that he believes the injury is a result of the GARDASIL vaccine. The reporters causality assessment was not provided. Additional information has been requested.
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